NCT05772559 Acute Myeloid Leukemia At Initial Diagnosis and/or Relapse in Children, Teenagers and Young Adults: Molecular Profiling, Multidrug Testing and MSC Interaction Studies
| NCT ID | NCT05772559 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Acute Myeloid Leukemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-05-31 |
| Primary Completion | 2033-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2023-05-31 with a primary completion date of 2033-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Pediatric acute myeloid leukemias are disease with poor prognosis (overall survival of 60-75%) and high relapse rate of 35-45% require further understanding of the underlying biological mechanisms. The main objective of this study is to establish a biological collection to evaluate the genomic profiling of leukemic cells from primary blasts at diagnosis and/or relapse to improve identification of the main genetic hits involved in resistance and could predict a high risk of relapse. Other objectives include the study of bone marrow mesenchymal stem cells and ex vivo drug testing.
Eligibility Criteria
Inclusion Criteria: * 0-25 years old * Newly diagnosed de novo or secondary Acute Myeloid Leukemia (AML) or * Relapsed or refractory AML or * Patients with genetic predisposition to develop AML or * Patients without haematological malignancy nor AML genetic predisposition syndrome who undergo bone marrow aspirate as part of standard of care * Signed informed consent of parents for patients aged less than 18 years old or signed informed consent of the patient for patients aged 18 and over. Exclusion Criteria: * Refuse to participate * Chronic myeloid leukemia (CML) * Lack of health insurance (French social security) * Under protection (tutelle, curatelle or sauvegarde de justice) * Pregnancy or breastfeeding
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05772559 clinical trial?
This trial is open to participants of all sexes, up to 25 Years, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05772559 currently recruiting?
Yes, NCT05772559 is actively recruiting participants. Contact the research team at arnaud.petit@aphp.fr for enrollment information.
Where is the NCT05772559 trial being conducted?
This trial is being conducted at Amiens, France, Angers, France, Besançon, France, Bordeaux, France and 11 additional locations.
Who is sponsoring the NCT05772559 clinical trial?
NCT05772559 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 500 participants.
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